Trajectory-Based Prognostic Modeling in Hepatocellular Carcinoma

NCT07204262 | Completed DMC

• 1 other identifier: KY2024-179
• Study Type: observational
• Target: 379
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate whether tracking changes in key blood markers over time, together with clinical features, can improve the prediction of outcomes in patients with hepatocellular carcinoma (HCC). By developing a trajectory-based prognostic model, we aim to provide more accurate risk assessment and support personalized treatment decisions.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Progression-Free Survival (PFS)

  To analyse the Progression-Free Survival (PFS) of patients

  Up to approximately 3 years

Secondary Outcomes (1)

• Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)

  Up to approximately 3 years

Study Arms (1)

Advanced HCC Cohort

This cohort includes patients with advanced hepatocellular carcinoma (HCC) who received systemic therapy with molecular targeted agents (TKIs or anti-VEGF antibodies) and/or PD-(L)1 inhibitors, with or without interventional treatments such as transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC). Clinical, radiological, and laboratory data were collected retrospectively to evaluate longitudinal biomarker trajectories and construct prognostic models.

Combination Product: Molecular Targeted Therapy (TKI / anti-VEGF antibody) PD-(L)1 Inhibitor Immunotherapy Interventional Therapy (TACE / HAIC)

Interventions

Molecular Targeted Therapy (TKI / anti-VEGF antibody) PD-(L)1 Inhibitor Immunotherapy Interventional Therapy (TACE / HAIC) COMBINATION_PRODUCT

Patients in this study received systemic therapy with molecular targeted agents, including tyrosine kinase inhibitors (TKIs) and anti-VEGF antibodies, and/or PD-(L)1 inhibitor immunotherapy. Some patients also received interventional therapies such as transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC). Treatment regimens, combinations, and sequencing were determined based on physician discretion and patient clinical status. This study focuses on the longitudinal monitoring of biomarkers during these therapies to evaluate their prognostic value and to develop a trajectory-based risk stratification model for advanced hepatocellular carcinoma (HCC).

Advanced HCC Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with advanced hepatocellular carcinoma (HCC), age ≥18 years, with complete baseline and follow-up clinical, radiological, and laboratory data who received systemic or interventional therapy. Patients with non-primary liver cancer, missing data, incomplete follow-up, or unevaluable lesions were excluded.

You may qualify if:

• pathologically or radiologically confirmed HCC;
• availability of pre- treatment clinical record, radiological and hematological data and more than 2 cycles of post-treatment data;
• receipt of treatment during the study period;
• Age rather than 18 years old.

You may not qualify if:

• baseline data missed;
• Non-primary liver cancer;
• incomplete follow-up data;
• Unevaluable lesions.

Sponsors & Collaborators

• Xu Yong, MD: lead

Study Sites (1)

Shenzhen Third People's Hospital

Shenzhen, Guangdong, 518112, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin-fixed, paraffin-embedded (FFPE) pathological tissue slides from tumor samples

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Molecular Targeted Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Yong Xu, Dr

  Shenzhen Third People's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Secretary of the Party Committee & Principal Investigator

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: January 1, 2018
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)